Label: ESOMEPRAZOLE MAGNESIUM tablet, delayed release
- NDC Code(s): 43598-469-28, 43598-469-42, 43598-469-52
- Packager: Dr. Reddys Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 15, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
Warnings
Allergy alert: Do not use if you are allergic to esomeprazole
Do not use
-
trouble or pain swallowing food, vomiting with blood, or bloody or black stools
-
heartburn with lightheadedness, sweating or dizziness·
-
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadness·
-
frequent chest pain
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if
- had heartburn over 3 months. This may be a sign of a more serious condition.·
- frequent wheezing, particularly with heartburn·
- unexplained weight loss·
- nausea or vomiting·
- stomach pain
Ask a doctor or pharmacist before use if
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
-
-
Directions
- adults 18 years of age and older·
- this product is to be used once a day (every 24 hours), every day for 14 days·
- may take 1 to 4 days for full effect
14-Day Course of Treatment
- swallow 1 tablet with a glass of water before eating in the morning·
- take every day for 14 days
- do not take more than 1 tablet a day
- swallow whole. Do not crush or chew tablets
- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
-
you may repeat a 14-day course every 4 months·
-
do not take for more than 14 days or more often than every 4 months unless directed by a doctor
-
children under 18 years of age, ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
- Other information
- Storage
-
Inactive ingredients
crospovidone, glyceryl monostearate, hypromellose, iron oxide red, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, simethicone, sodium stearyl fumarate, sugar spheres (contains sucrose and maize starch), talc, titanium dioxide, triethyl citrate
- Questions
-
SPL UNCLASSIFIED SECTION
Tips for Managing Heartbun
- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chDistocolate, caffeine, alcohol and even some acidic fruits and vegetables
- Eat slowly and do not eat big meals.
- Do not eat late at night or just before bedtime
- Do not lie flat or bend over soon after eating
- Raise the head of your bed.
- Wear loose-fitting clothing around your stomach
- If you are overweight, lose weight
- If you smoke, quit smoking.
Distributor:
Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540
Made in India
Issued: 0420
- Principal Display Panel
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-469 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole 20 mg Inactive Ingredients Ingredient Name Strength Crospovidone (UNII: 2S7830E561) Glyceryl Monostearate (UNII: 230OU9XXE4) Hypromelloses (UNII: 3NXW29V3WO) Ferric Oxide Red (UNII: 1K09F3G675) Magnesium Stearate (UNII: 70097M6I30) Mannitol (UNII: 3OWL53L36A) Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J) Cellulose, Microcrystalline (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Polysorbate 80 (UNII: 6OZP39ZG8H) Dimethicone 350 (UNII: 2Y53S6ATLU) Sodium Stearyl Fumarate (UNII: 7CV7WJK4UI) Sucrose (UNII: C151H8M554) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Triethyl Citrate (UNII: 8Z96QXD6UM) Product Characteristics Color PINK (light pink) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 469 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43598-469-52 1 in 1 CARTON 11/15/2020 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:43598-469-28 2 in 1 CARTON 11/15/2020 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:43598-469-42 3 in 1 CARTON 11/15/2020 3 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211571 11/15/2020 Labeler - Dr. Reddys Laboratories Inc (802315887)